{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48579",
      "product_res_number": "Z-0326-2007",
      "event_date_initiated": "2004-10-12",
      "event_date_posted": "2006-12-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-01",
      "res_event_number": "36396",
      "product_code": "DTQ",
      "k_numbers": [
        "K022947"
      ],
      "product_description": "Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110.",
      "code_info": "Serial numbers 00023 through 00026, 00034, 00041, 00051, 00060, 00063 through 00065, 00067 through 00069, 00071  through 00089, 00091 through 00139, 00141 through 00242, 00246 through 00280, 00282 through 00297, 00299 through 00323, 00325 through 00410 and 00419.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corp",
      "address_1": "6200 Jackson Rd",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "800-521-2818",
      "reason_for_recall": "Device module(s) may fail to properly initialize during start up, thus resulting in that  single module being inoperable and a red 'X' being displayed on the monitor screen.",
      "root_cause_description": "Other",
      "action": "U.S. consignees were sent an addendum to the operators manual on October 12, 2004 instructing them to cycle power to the unit to clear the error.  International distributors were requested to provide this information to their customers on 12/15/04, but Terumo has not yet received confirmation that this was completed.",
      "product_quantity": "4,740 for all affected products",
      "distribution_pattern": "Worldwide Distribution-USA and countries Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.",
      "openfda": {
        "k_number": [
          "K080832",
          "K813034",
          "K202125",
          "K221373",
          "K942582",
          "K002116",
          "K103762",
          "K030141",
          "K915183",
          "K060053",
          "K964017",
          "K011088",
          "K052555",
          "K002118",
          "K153376",
          "K210130",
          "K851614",
          "K090006",
          "K172220",
          "K020571",
          "K842138",
          "K070213",
          "K943803",
          "K851615",
          "K861388",
          "K772001",
          "K131041",
          "K982014",
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          "K022947",
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          "K862973",
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          "K863541",
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          "K173834",
          "K801097",
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          "K092463",
          "K870976",
          "K093882",
          "K190282",
          "K163531",
          "K091007",
          "K071318"
        ],
        "registration_number": [
          "3019807891",
          "3010703925",
          "8010762",
          "9611109",
          "1828100",
          "3005941719",
          "3007427881",
          "3011554160",
          "2916596",
          "3001589655",
          "2184009",
          "9680841",
          "3006073153",
          "1218444",
          "3042990265",
          "3010163695",
          "3002807090",
          "3009507273"
        ],
        "fei_number": [
          "3019807891",
          "3010703925",
          "3006003617",
          "1828100",
          "3007427881",
          "3011554160",
          "3001589655",
          "2916596",
          "3005426550",
          "1000116158",
          "3009649876",
          "3002808267",
          "3006073153",
          "3002807111",
          "1218444",
          "3042990265",
          "3010163695",
          "3009507273"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}